ISO 13485 ISO 13485 ISO 13485

Homepage // News Center // Avient Site in Glendale, Arizona Earns ISO 13485 Certification The Avient facility in Glendale, AZ recently received ISO 13485 certification demonstrating the company’s commitment to providing healthcare solutions. ISO 13485 is an internationally recognized standard for quality management systems in the medical device industry.

To support this, Avient’s medical-grade colorants and additives are manufactured at sites certified under GMP or ISO 13485-2016 standards. Additionally, Avient’s ISO 13485 manufacturing site in Singapore for its Mevopur™ formulations recently achieved ISO/IEC 17025 accreditation for Biological Evaluation of Medical Devices–Part 5: Tests for In-Vitro Cytotoxicity.  They are manufactured at an ISO13485-2016-certified site and pre-tested to specific regulatory demands, including USP Class VI and ISO 10993.

Homepage // News Center // Avient Site in Taiwan Earns ISO 13485 Accreditation; Fourth Source for MEVOPUR™ ‘Medical-Grade’ Materials Caption: Avient Corporation today announced the ISO 13485:2016 certification of its production site in Taoyuan, Taiwan (near Taipei). ISO 13485 certification is the culmination of two years’ work to create a completely segregated, dedicated healthcare operation similar to other MEVOPUR plants.

Avient Site in Taiwan Earns ISO 13485 Accreditation; Fourth Source for MEVOPUR™ ‘Medical-Grade’ Materials Caption: Avient Corporation today announced the ISO 13485:2016 certification of its production site in Taoyuan, Taiwan (near Taipei).

Avient Site in Glendale, Arizona Earns ISO 13485 Certification The Avient facility in Glendale, AZ recently received ISO 13485 certification demonstrating the company’s commitment to providing healthcare solutio

Global network of ISO 13485 certified manufacturing sites ISO 6009 color range Mevopur™ formulations for PCR well plates prevent 'cross-talk' and minimize phosphorescence with optimally dispersed TiO2, while balancing melt flow and physical properties, and ensuring quality through ISO 13485:2016 certification.

This encompasses the principles of change control management, good manufacturing practices (GMP) and the ISO13485 quality standard, as well as regulatory support service. In addition, some specialized products are produced in internally-certified sites operating under the same ISO13485 Standard Operating Procedures (SOP). Internal ISO13485 GMP is in operation at two additional specialist sites in Europe.

This encompasses the principles of change control management, good manufacturing practices (GMP) and the ISO13485 quality standard, as well as regulatory support service. In addition, some specialized products are produced in internally-certified sites operating under the same ISO13485 Standard Operating Procedures (SOP). Internal ISO13485 GMP is in operation at two additional specialist sites in Europe.

This encompasses the principles of change control management, good manufacturing practices (GMP) and the ISO13485 quality standard, as well as regulatory support service. In addition, some specialized products are produced in internally-certified sites operating under the same ISO13485 Standard Operating Procedures (SOP). Internal ISO13485 GMP is in operation at two additional specialist sites in Europe.